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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05434026
Other study ID # CCCD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 3, 2022
Est. completion date June 22, 2032

Study information

Verified date August 2022
Source Beijing Friendship Hospital
Contact Zhongtao Zhang
Phone 13801060364
Email zhangzht@ccmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1. To establish the Chinese people's own clinical data database of colorectal cancer, reflecting the law and characteristics of colorectal cancer patients in China. 2. Based on colorectal cancer surgery, collect clinical data, especially data on clinical manifestations, complications, laboratory tests, auxiliary examinations, postoperative clinical effects, surgical complications, and colorectal cancer recurrence, so as to lead the direction of clinical practice and academic research of colorectal cancer surgery in China. It provides a certain basis for future research on colorectal cancer. 3. Provide academic consultation and data support to national health authorities.


Recruitment information / eligibility

Status Recruiting
Enrollment 200000
Est. completion date June 22, 2032
Est. primary completion date June 22, 2032
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - adenocarcinoma of the colon by biopsy - tolerable to surgery - be able to understand and willing to participate in this trial with signature Exclusion Criteria: - can not tolerate the surgery - history of serious mental illness - the researchers believe the patients should not enrolled in

Study Design


Locations

Country Name City State
China Zhongtao Zhang Beijing

Sponsors (8)

Lead Sponsor Collaborator
Beijing Friendship Hospital Beijing Chao Yang Hospital, First Hospital of China Medical University, Peking Union Medical College Hospital, Peking University Cancer Hospital & Institute, Peking University People's Hospital, Ruijin Hospital, The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Positive rate of circumferential resection margin (CRM) of the specimens Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while >1mm is negative. 10 days after surgery
Primary The grade score of the specimens integrity shows the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see >5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3. 10 days after surgery
Primary The distance between lower tumor margin and the lower reaction margin shows the oncological safety of the surgery by pathological examination. Reports should contain the distance between lower tumor margin and the lower reaction margin. 10 days after surgery
Primary local recurrence rate show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not. 3 years after surgery
Primary the operative time preoperative safety containing operation information, complication information. 30 days after surgery
Primary postoperative hospital stay recovery information. 3 year after surgery
Primary the score of postoperative life quality of life contains two scales: Wexner scale and EORTC QLQ-CR29 scale, which show quality of life and the anal function. 6 months after surgery
Primary disease free survival rate show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not. 3-year after surgery
Primary overall survival rate show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not. 3-year after surgery
Primary the rate of postoperative complications preoperative safety containing operation information, complication information. 30 days after surgery
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